Medical and surgical patients are commonly intubated or have a tube installed into their trachea to allow mechanical ventilation. In these patients, it is sometimes required in their medical management to install a second catheter through the endotracheal tube for some specific purpose. These second catheters may be placed for monitoring or therapy. Parameters which may be monitored may be gas composition,pressure or temperature. Therapy which may be delivered may include jet ventilation, the placement of a balloon tipped catheter to obstruct a portion of the airway or any other therapy which be delivered using a second catheter installed through an endotracheal tube. These catheters may lie past the end of the endotracheal tube and should be positioned and inspected through the endotracheal tube with a flexible fiberoptic bronchoscope, a flexible fiberoptic instrument. Both the fiberoptic bronchoscope and the second catheter will need to be installed through a manifold capable of allowing simultaneous ventilation, fiberoptic bronhoscopy, and airway instrumentation. The manifold must be capable of forming a gastight seal following introduction and removal of the fiberoptic bronchoscope. The manifold must also have a sealing mechanism to allow the second catheter to be positioned, be affixed in place, and reform a gastight seal if pulmonary physiology changes causing gas leakage past the seal from higher ventilation pressures.
The most relevant, known ventilating instrumentation prior art patent is U.S. Pat. No. 4,351,328. In this patent by Bodai, a manifold is provided for airway insertion of an instrument, most commonly, a fiberoptic bronchoscope, while maintaining mechanical ventilation of either a medical or surgical patient. Difficulty has been encountered when in placing two instruments simultaneously into the airway. Often the technique required by the prior art requires two manifolds placed in series making the procedure cumbersome, time consuming, and traumatic for the patient. The prior art valve mechanism does not allow an instrument to be fixed in place or form a reliable airtight seal necessary for long periods, several hours of instrumentation.
In U.S. Pat. Nos. 5,333,607 and 5,628,306 Kee describes a ventilator manifold with an accessory port for the introduction of a catheter tube into the endotracheal tube of an intubated patient. This manifold incorporates an accessory port with a valve normally held in the closed position. The accessory port is opened with the attachment of an accessory device to open the valve and allow introduction of the catheter tube. This device does not allow the compressive force of the enclosed diaphragmatic valve to be varied against the outer wall of the inserted catheter tube. The device also requires the use of an accessory device to open the valve which in clinical practice is cumbersome requiring the presence of the accessory device or a special catheter tube incorporating the accessory device into its construction.
The literature describes common medical procedures requiring simultaneous fiberoptic bronchoscopy and airway instrumentation with a catheter tube and disclose the difficulty of simultaneous instrumentation and bronchoscopy of the airway.
The prior art describes a manifold to allow instrumentation of a medical or surgical patient's airway while being mechanically ventilated using an endotracheal tube previously placed in the patient's trachea. However, the prior art does not allow simultaneous fiberoptic bronchoscopy and airway instrumentation with a second instrument being tubular in shape. The prior art has a number of disadvantages.
a) The manifold does include an accessory port for the introduction of a second instrument following introduction of a fiberoptic bronchoscope. PA1 b) The instrumentation port seals do not form an airtight seal following the placement of a second instrument. This allows leakage of ventilation gases and possible patient harm. PA1 c) The instrument port seals are not adjustable in the amount of compression exerted on the instrument. Compression may need to be adjusted to prevent instrument damage or to stop a leakage of ventilating gases if pulmonary physiology changes requiring a higher ventilation pressure from a mechanical ventilator. PA1 d) The instrumentation port does not allow the instrument to be affixed in position after correct positioning using a fiberoptic bronchoscope. PA1 a) to provide a manifold with a minimum of four ports for mechanical ventilation, connection to an endotracheal tube, fiberoptic bronchoscopy, and secondary simultaneous instrumentation. PA1 b) to provide a secondary instrumentation port constructed of a threaded port with a threaded open ended cap with a deformable perforated elastic diaphragm between the port and cap. PA1 c) to provide variable tension or compression on the outer surface a secondary tubular instrument inserted through the secondary instrumentation port by screwing or torquing the cap so as to compress the diaphragm between the threaded port and cap. PA1 d) to provide a means of stopping the loss of ventilatory gases during mechanical ventilation through the instrumentation port during chronic instrumentation by torquing the end cap to increase the tension or compression of the diaphragm around the outer wall of the secondary instrument. PA1 e) to provide a means of affixing the secondary tubular instrument in position in relation to the manifold, endotracheal tube and patient airway after correct positioning using a fiberoptic bronchoscopy by torquing the end cap to compress the tubular secondary instrument and deformable perforated elastic diaphragm against each other affixing the secondary instrument in place. PA1 f) to provide a secondary instrumentation port oriented at an angle in relation to the bronchoscopy port to provide optimal introduction of the secondary tubular instrument into the body of the manifold.